Ignite Creation Date:
2024-05-06 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 12:51 PM
Study NCT ID:
NCT03620266
Status:
RECRUITING
Last Update Posted:
2024-04-15
First Post:
2018-08-02
Brief Title:
Effects of Bilberry and Oat Intake After Type 2 Diabetes andor MI
Sponsor:
Ole Frobert MD PhD
Organization:
Region Örebro County
Study Overview
Official Title:
Effects of Bilberry and Oat Intake on Plasma Lipid Profile Inflammation and Exercise Capacity in Patients With Type 2 Diabetes andor Myocardial Infarction BioDiaMI a Randomized Double-blind Placebo-controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BioDiaMI
Brief Summary:
Background
Bilberries from Sweden rich in polyphenols have shown cholesterol-lowering effects in small studies and the cholesterol-lowering properties of oats with abundant beta-glucans and potentially bioactive phytochemicals are well established Both may provide cardiometabolic benefits for patients with manifest chronic cardiometabolic disease such as type 2 diabets mellitus T2DM and myocardial infarction MI However large studies of adequate statistical power and appropriate duration are needed to confirm clinically relevant treatment effects No previous study has evaluated the potential additive or synergistic effects of bilberry combined with oats on cardiometabolic risk factors
Design
This is a double-blind randomized placebo-controlled clinical trial Our primary objective is to assess cardioprotective effects of diet supplementation with dried bilberry and with bioprocessed oat bran with a secondary explorative objective of assessing their combination compared with a neutral isocaloric reference supplement for patients diagnosed with T2DM andor MI Patients will be randomized 1111 to a three-month intervention The primary endpoint is the difference in LDL cholesterol change between the intervention groups after three months The major secondary endpoint is exercise capacity at three months Other secondary endpoints include plasma concentrations of biochemical markers of inflammation glycaemia and gut microbiota composition after three months
Implications
Secondary prevention after cardiometabolic disease including T2DM and MI has improved during the last decades but diabetes complications readmissions and cadiovascular related deaths following these conditions remain large health care challenges Controlling hyperlipidemia hyperglycaemia hypertension and inflammation is critical to preventing new cardiovascular events but novel pharmacological treatments for these conditions are expensive and associated with negative side effects If bilberry andor oat in addition to standard medical therapy can lower LDL cholesterol and inflammation more than standard therapy alone this could be a cost-effective and safe dietary strategy for secondary prevention in high-risk patients or risk prevention in subjects with T2DM
Bilberries from Sweden rich in polyphenols have shown cholesterol-lowering effects in small studies and the cholesterol-lowering properties of oats with abundant beta-glucans and potentially bioactive phytochemicals are well established Both may provide cardiometabolic benefits for patients with manifest chronic cardiometabolic disease such as type 2 diabets mellitus T2DM and myocardial infarction MI However large studies of adequate statistical power and appropriate duration are needed to confirm clinically relevant treatment effects No previous study has evaluated the potential additive or synergistic effects of bilberry combined with oats on cardiometabolic risk factors
Design
This is a double-blind randomized placebo-controlled clinical trial Our primary objective is to assess cardioprotective effects of diet supplementation with dried bilberry and with bioprocessed oat bran with a secondary explorative objective of assessing their combination compared with a neutral isocaloric reference supplement for patients diagnosed with T2DM andor MI Patients will be randomized 1111 to a three-month intervention The primary endpoint is the difference in LDL cholesterol change between the intervention groups after three months The major secondary endpoint is exercise capacity at three months Other secondary endpoints include plasma concentrations of biochemical markers of inflammation glycaemia and gut microbiota composition after three months
Implications
Secondary prevention after cardiometabolic disease including T2DM and MI has improved during the last decades but diabetes complications readmissions and cadiovascular related deaths following these conditions remain large health care challenges Controlling hyperlipidemia hyperglycaemia hypertension and inflammation is critical to preventing new cardiovascular events but novel pharmacological treatments for these conditions are expensive and associated with negative side effects If bilberry andor oat in addition to standard medical therapy can lower LDL cholesterol and inflammation more than standard therapy alone this could be a cost-effective and safe dietary strategy for secondary prevention in high-risk patients or risk prevention in subjects with T2DM
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None